After two days of hearings, several members of an 11-member advisory panel of the U.S. Food and Drug Administration found that there are not yet sufficient data to determine that a genetic modification that enables salmon to grow twice as quickly is safe for the affected fish or for consumers.

The panel, made up of outside experts, did not vote or make a recommendation on whether to approve these fish for human consumption….

Most of what’s in the story (other than the non-decision itself) is not new, and will be familiar to everyone who has been following this story.

It’s worth mentioning that this story gives just a hint at the complexity of the FDA’s decision-making process, which includes at least the following:

The Commissioner (currently Dr. Margaret A. Hamburg);

The panel of outside experts, charged with making a recommendation to the Commissioner;

Staff scientists (who produced the report submitted to the panel)

Scientists for AquaBounty, who generated data to submit to the FDA;

And then, of course, there’s the public commentary process — a process which critics have said was inadequate, in this case.

As I’ve noted elsewhere, there’s plenty of criticism out there regarding the effectiveness of the FDA in general (see How Good (or Bad) is the FDA?). One of the key worries has been about political and corporate interference. Understanding the key contributors to a regulatory decision — including the key pieces of the FDA’s own process — is crucial to figuring out a) just how good (or bad) the FDA is at its job, and b) how to make the process better.

3 Responses to No Decision About GM Salmon

I have to admit that I don’t really understand the public comment process. It makes a lot of sense to have stakeholder groups present information from their constituencies, but how many times does a USDA employee need to read “I don’t want to eat DNA” and other such oddities from individuals? The stakeholder group would have the time and funding to present some sort of (hopefully) reasoned argument for or against any particular deregulation, but the individual comments ( based on the public comments that I have read) are for the most part anything but reasoned. We can’t even argue that the USDA just wants to get a general feel of what the public wants because the only people who comment are either really confused about the science or have strong ideological issues with the subject or they are industry representatives from one side or another. Individual comments seem like a waste of time and money. Instead, they should accept comments from groups, and anyone is free to organize a group if they wish.

You have a point. But I think that, in a democracy, *some* sort of system for public commentary is essential. Most voters in general elections are uninformed, too, but we still have to let them vote. I think the deepest criticism is that public consultations are never remotely representative. Luckily, we don’t often let public consultation fully determine these sorts of decisions. But I think the input is still important.

Biotech Ethics BLOG

This blog is about ethical issues in the biotechnology industry. That includes all 3 main areas of that industry: health biotech, food biotech, and industrial biotech. (The last two are particularly important, and don't get enough attention.)

Unlike my Business Ethics Blog, this one will focus on aggregating information, rather than offering much commentary.